January 9, 2024

The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities about the potential for exposure to certain chemicals that may be released when General Electric (GE) HealthCare accessory components called the EVair or EVair 03 (Jun-air) compressors are used with certain ventilators. Compressors are optional accessories for ventilators and used when wall air is not available. 

On December 29, 2023, GE HealthCare issued an Urgent Medical Device Correction to inform users about the potential for elevated levels of formaldehyde based on preliminary testing when the EVair or Jun-Air optional compressors are used with the Carescape R860 or Engström Carestation/Pro ventilators, respectively.  GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde. 

The FDA is not aware of reports of adverse events due to this issue to date. 

The FDA is issuing this letter to help ensure you are aware of the manufacturer's recall notice and the recommended actions.

Recommendations

• Review the Urgent Medical Device Correction notice from GE HealthCare for the EVair and EVair 03 (Jun-Air) Compressors, which includes model numbers and Unique Device Identifier (UDI) information.
• Do not use EVair and EVair 03 (Jun-Air) compressors to supply air to ventilators for neonatal and infant patients (0-2 years of age).
• Be aware that GE HealthCare is lowering the maximum room air temperature for operation of the compressors from 40 degrees C (104 degrees F) to 30 degrees C (86 degrees F) to further reduce the potential for patient exposure to formaldehyde.
• Be aware that GE HealthCare is updating user instructions with the updated operating conditions (30 degrees C (86 degrees F) maximum room air temperature) and indications for use specifying that the compressors are not recommended for use with neonates and infants (0-2 years of age).
• Report any issues with use of the compressors to the FDA.

Background

The EVair compressor is intended for use with a Carescape R860 ventilator as a supply of compressed air. 

The EVair03 (Jun-Air) compressor is intended for use with an Engstrom Carestation/Pro ventilator as a supply of compressed air. 

Exposure to elevated levels of formaldehyde may lead to problems such as neurological impairment or respiratory problems (such as asthma, decreased lung function, inflammation, or irritation), which is particularly concerning for neonates and infants (0-2 years of age) who may have immature pulmonary function or other coexisting conditions. 

FDA Actions

The FDA is working with GE HealthCare to conduct additional testing to further evaluate this issue. 

The FDA will continue to keep health care providers and the public informed if significant, new information or recommendations become available.

Unique Device Identifier (UDI)

The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. For more information on UDI, please visit Unique Device Identification System (UDI Systems). 

Reporting Problems to the FDA

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with any medical device. Prompt reporting can help the FDA identify and better understand the risks associated with medical devices and improve patient safety.

• Health care personnel employed by facilities that are subject to the FDA's User Facility Reporting Requirements should follow the reporting procedures established by their facilities.
• Voluntary reports can be submitted through MedWatch: The FDA Safety Information and Adverse Event Reporting program.
• Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.

Contact Information

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).